COVID-19 and Radiation Oncology: a 2-phase planning in a mono-institutional experience in Central Italy

Background: COVID-19 in Italy has led to a reorganization of hospital activities with risks of cancer treatments discontinuity. We report a management model in the two phases of the COVID-19 emergency, lockdown phase I and post-lockdown phase II. Methods: Actions were planned in the two phases: workloads of the visits and radiotherapy planning, dedicated routes, measures for triage areas, management of suspected and positive COVID-19 cases, personal protective equipment, environments andintra-institutional meetings and tumor boards management. Results: Comparing our radiotherapy activity in the period March 9- May 4, 2019 with the same period of 2020 in full phase I of the COVID-19 emergency, no changes were observed. First radiotherapy visits, Simulation Computed Tomography and Linear Accelerators treatments were 123, 137 and 151 in 2019 respect to 121, 135 and 170 in 2020. There were no cases of COVID-19 positivity recorded either in patients or in healthcare professionals who were all negative to the buffers performed. Conclusions: The model planned in our experience in both phases has guaranteed continuity of radiotherapy treatments without workload reduction nor treatment interruption ensuring safety of cancer patients, environments and staff.


Introduction
The rapid and uncontrolled spread of COVID-19 in some regions and provinces of northern Italy led to the declaration of partial and complete lockdown of the entire country by the national government between March 8 and March 22, 2020 and this phase, called Phase I, lasted from March 9 to May 3, 2020 [1][2][3]. From May 4, 2020 the so-called Phase II was approved, a gradual slowdown of the phase I thanks to the descent of the epidemic curve [4] (Figure 1). At June 7, 2020 Italy recorded a total of 234,998 COVID-19 cases, 168,640 recovered, 32,459 in home isolation and 33,899 deaths [5]. Until the middle of April, the number of patients hospitalized in the intensive and non-intensive care units was progressively important with the consequent need for a complete reorganization of the hospitals. The territorial heterogeneity of the COVID-19 trend has seen a decisive and dramatic prevalence in the areas of northern Italy and a more contained incidence in the areas of central and southern Italy ( Figure 2) [5].
Abruzzo, a region of central Italy with a population of 1,304,970 people, recorded at June 7, 2020 a total number of cases of 3,265 (1.39%) with a peak of infections on March 29, 2020, a maximum hospital load on April 3, 2020, 418 deaths, 2,215 recovered and 632 in home isolation [6] (Figure 3). Therefore, although with smaller numbers, the Abruzzo region also experienced an important distress and centered COVID-19 reorganization of hospital activities with the interruption on March 13, 2020 of all scheduled hospitalizations both medical and surgical with the exception of onco-hematological services non-deferrable at clinical judgment. In fact, for cytostatic, radiation oncology or immunological treatments, the Ministry of Health has recommended to the local Health Authorities to guarantee these "life-saving" treatments to all patients and to plan paths and spaces dedicated to patients being treated as well as all individual protective devices necessary [7][8]. In this regard, the Italian Association of Radiotherapy and Clinical Oncology (AIRO) worked out a document to make homogeneous the radiotherapy operating procedures during the ongoing COVID-19 emergency [9] and conducted a targeted national survey [10]. Furthermore, several experiences have been published on the management of radiation therapy during this pandemic time [11][12][13][14][15][16][17]. We report our experience in the organizational planning of radiotherapy in the two phases of the COVID-19 emergency, the lockdown phase I and the post-lockdown phase II in order to guarantee continuity of treatments, the safety of cancer patients and of healthcare personnel within a framework of complete reorganization COVID-19 centered at the University Hospital of Chieti.

Materials And Methods
Radiation Oncology Center of Chieti is one of the four Radiotherapy centers in the Abruzzo region, it is equipped with two Linear Accelerators (Linacs) that both work with a double workshift from 8.00 a.m. to 8.30 p.m., a Simulation Computed Tomography (Simul CT) and clinical dosimetry that in ordinary regime work from 8.00 a.m. to 2.00 pm, a clinic room dedicated to the rst radiotherapy visits and a clinic room dedicated to the follow-up of cancer patients both with ordinary workshift from 8.00 am to 2.00 pm, an oncological day-hospital unit for the management of concurrent radio-chemotherapy treatments.
The Radiotherapy staff is composed of 11 doctors, 14 technicians, 3 dedicated physicists, 5 nurses, 2 administrative staff, a socio-health operator, a secretary. The center is also a university site with a specialization school in Radiation Oncology with a total of 7 resident doctors and for a total staff of 44 units. An average of around 800 patients are treated each year. Table 1 shows the arrangement actions of the radiotherapy activities planned with the Hospital Management and the Hospital Quality O ce, respectively, in lockdown phase I and in post-lockdown phase II of the COVID-19 pandemic time.

Results
Comparing the center activity in the period March 9-May 4, 2019 in ordinary routine conditions, with the same time interval March 9-May 4, 2020, in full lockdown phase I of the COVID-19 emergency, no changes were observed on the number of services performed. Particularly, in 2019, 123 rst radiotherapy visits were performed, 137 new patients were prepared for Simul CT and 151 patients were treated on Linear Accelerators. In the same period of 2020 and during the pandemic critical phase, planned actions allowed to perform 121 rst radiotherapy visits, 135 new patients were prepared for Simul CT and 170 patients were treated on Linear Accelerators (Table 2). Dose hypofractionation has been predominantly used in breast, prostate and palliative treatments. There were no cases of COVID-19 positivity recorded in patients or in healthcare professionals both in phase I and in phase II. About it, in the week from May 25 to May 31, 2020 all the staff of the Center underwent oropharyngeal and nasopharyngeal buffer with negative results in 42 examined. Two workers have not been examined since, respectively, in maternity and illness since last year.

Discussion
The serious COVID-19 pandemic that hit Italy led to a serious suffering for the national hospital system which had to reorganize the assistance network with centered COVID-19 hospitals and with a prevalence of intensive and sub-intensive care units. Many internal and surgical departments have been reconverted and dedicated to the management of COVID-19 in a few weeks and also the radiological and laboratory diagnostic activities have been seriously involved. Although with more contained case numbers than in the regions and provinces of northern Italy, the main hospitals in the Abruzzo region and, speci cally from our experience, the University Hospital of Chieti, were reorganized in this direction in a short time. This situation led to a double risk: potential and dangerous delays or interruptions in oncological therapies, considered "lifesaving" treatments in patients who are often already frail and a high risk of infections in patients, carers and health personnel. Several scienti c documents and papers published in the literature represented an important reference especially in the rst phase of the emergency [11][12][13][14][15][16][17] and with regard to the use of protection systems, triage procedures and the use of hypofractionation schemes. In particular, a national survey conducted by the Italian Society of Radiotherapy and Clinical Oncology and even before a survey of the radiotherapy centers of the Lombardy region, the region most affected by COVID-19 [10,14], reported the measures adopted by the centers for the arrangement of the centers, the workloads and the COVID-19 cases found. Most of the measures adopted and reported in the surveys are in line with the planned approach in our experience with the exception of the "working from home mode" which cannot be used in our center due to the absence of dedicated technology. Overall, the clinical activity of the Italian centers underwent a reduction of <10% in 32% of cases and between 10-30% of cases in 30.4%. In our experience, the clinical activity in the lockdown phase was comparable to the clinical activity of the same observation period of 2019 and, except for a rescheduling of the oncological follow-up visits, there were no interruptions of the treatments nor a reduction in the radiotherapy preparation and in the beginning of new cancer patients. The national survey also reports 29.6% of the positive or suspect cases treated in Italian centers. No positive or suspicious cases were found in our experience both in phase I and in phase II. However, the difference on the reduction of workloads and on the number of positive or suspect patients reported in the national survey consists in the predominance of the COVID-19 cases in the regions of northern Italy and in particular in Lombardy where 10-50% reduction in radiotherapy workloads has been registered, but also in greater organizational awareness due to the increase of national and international guidelines emerging in the meantime in the literature and in the detailed recommendations on the individual tumor pathologies treated in terms of use of hypofractionated regimens [22][23][24][25][26]. In our experience, dose hypofractionation has been used in breast, prostate and palliation cancers.

Conclusions
The organizational model implemented in our experience, respectively, in the lockdown phase I and in the post-lockdown phase II has ensured an optimal continuity of radiotherapy work ow without reducing the workload and without interrupting the radiation therapy cycles, the safety of the cancer patients, of the environments and of the radiation oncology staff. It is therefore recommended that each Radiation Oncology center should customize its organizational model in the COVID-19 management based on the characteristics and directives of the Hospital and on the speci c features of the center in terms of equipment, staff and environments.   Preparation of a single pre-waiting room area for family members and carers. Entry into the Radiation Oncology center reserved for one family member and only for the first radiotherapy visits or on urgent cases 9 Triage area with nursing staff: a) entry for 4 patients at a time with a distance of at least 1 meter; b) body temperature detection with Thermo can; c) finding of respiratory symptoms, ocular disorders (conjunctivitis), dysgeusia and anosmia; d) contacts with suspected COVID-19 by filling of the dedicated Hospital questionnaire; e) obligation of surgical mask for patients and carers [18][19][20][21] Triage area with nursing staff: a) entry for 4 patients at a time with a distance of at least 1 meter; b) body temperature detection with Thermo can; c) finding of respiratory symptoms, ocular disorders (conjunctivitis), dysgeusia and anosmia; d) contacts with suspected COVID-19 by filling of the dedicated Hospital questionnaire; e) obligation of surgical mask for patients and carers [18][19][20][21] 10 Management of suspected case in triage for patients, staff, carers and third parties: if temperature ≥37.5 °r epetition after 10 minutes and if confirmed, access to the center is not allowed. Evaluation for deferral of planned clinical or technical performance: in the case of deferral, the patient is rescheduled; in the case of non-deferral, the patient accesses the service by adopting all the safety criteria indicated in points 12 and 13 [19] Management of suspected case in triage for patients, staff, carers and third parties: if temperature ≥37.5 °r epetition after 10 minutes and if confirmed, access to the center is not allowed. Evaluation for deferral of planned clinical or technical performance: in the case of deferral, the patient is rescheduled; in the case of non-deferral, the patient accesses the service by adopting all the safety criteria indicated in points 12 and 13 [19] 11 Alternate management of all staff in order to prevent potential multiple infections /  [18][19][20][21] with respiratory symptoms; b) Simul TC and Linear Accelerators: FFP2 mask with superimposed surgical mask and single-use gloves; systematic hand disinfection; visor or protective glasses for Head and Neck and respiratory tumors and for patients with respiratory symptoms [18][19][20][21] 13 Symptomatic and asymptomatic positive COVID-19 patient: medical evaluation for treatment interruption based on the clinical disease status, with monitoring of the clinical status and treatment recovery after 2 consecutive negative buffer, symptomatic absence and negative CT scan. In the case of treatment continuation because it cannot be deferred: preparation of separate paths; bunker disinfection before and after treatment; FFP2 masks with superimposed surgical mask; singleuse gloves and gowns; visors or protective glasses and overshoes for staff; separate and disinfected room for dressing and undressing [21] Symptomatic and asymptomatic positive COVID-19 patient: medical evaluation for treatment interruption based on the clinical disease status, with monitoring of the clinical status and treatment recovery after 2 consecutive negative buffer, symptomatic absence and negative CT scan. In the case of treatment continuation because it cannot be deferred: preparation of separate paths; bunker disinfection before and after treatment; FFP2 masks with superimposed surgical mask; singleuse gloves and gowns; visors or protective glasses and overshoes for staff; separate and disinfected room for dressing and undressing [21]